Califf Nomination for FDA Chief Gets Mostly High Marks

But ties with industry may be an issue

WASHINGTON -- The nomination of Robert Califf, MD, as FDA commissioner is getting good reviews from most health policy and cardiology experts.

"He has a very good understanding of industry and academia, and think that will serve him well," Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, told MedPage Today in a phone interview. "He built and grew the Duke Clinical Research Institute into a behemoth, so he has deep experience in drug development. On the medical products side, he has a deep and comprehensive understanding ... from manufacturers and academia, so I think he'll be very well suited there."

Harlan M. Krumholz, MD, of the Yale University School of Medicine in New Haven, Conn., agreed. "He ran one of the nation's leading clinical research groups that did studies across entire range of medicine," Krumholz said in an email. "He's a broad thinker and a very creative and visionary individual. He will be an outstanding choice."

Sanjay Kaul, MD, MPH, of Cedars-Sinai Heart Institute in Los Angeles, agreed. "I can't think of a more qualified person than Dr. Califf to lead the FDA at the present time," Kaul wrote in an email. "He is an accomplished leader in cardiovascular disease research whose work has resulted in therapies that save lives and improve the quality of life for millions of patients."

Champion of Change?

Califf was nominated on Tuesday by President Obama; he is currently serving as FDA's deputy commissioner for medical products and tobacco. Prior to that appointment, Califf was vice-chancellor for clinical and translational research at Duke University in Durham, N.C., where he also co-chaired the Clinical Trials Transformation Initiative, a public-private partnership co-founded by Duke and the FDA to identify and promote practices that will increase the quality and efficiency of clinical trials.

The experts differed on how much change Califf would bring. "The FDA is an ocean liner, and even with a change in leadership at top, I don't expect -- at least in the early transition period and a year or two after he assumes office, if he's confirmed -- any huge changes in the direction of the agency," said Alexander. "The direction is determined by many factors and needs beyond the perspective of the commissioner at the helm, and I don't expect there's likely to be a dramatic, abrupt shift in the agency's main priority areas."

But Steve Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic, disagreed. "He's not going to sit on his hands," Nissen said in a phone interview. "This is a guy who's going to make changes."

Industry Ties a Concern

One area that might cause controversy with Califf's nomination is his ties to the pharmaceutical industry. "His very close ties to industry [are] his greatest weakness from a public health point of view," Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank here that researches the safety of medical products for consumers, said in an email. "That's why Republicans have supported his nomination and many Democrats have opposed it. Those ties have also been a source of great concern to public health experts across the country."

"If he is confirmed, he will need to show his independence from industry in order to protect the safety of patients and the integrity of the FDA as a public health agency," she said. "This will be especially important because the 21st Century Cures Act, which passed the House overwhelmingly and is being revamped in the Senate, has the strong support of pharmaceutical and device companies, as well as academic researchers who depend on industry funding, as Dr. Califf did when he was at Duke."

But Public Citizen's Health Research Group, a consumer advocacy organization here, doesn't even want to give him the chance to try. "During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few," Michael Carome, MD, the group's director, said in a statement. "Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed."

"The Senate should reject Califf and demand that the president nominate someone who has not been so closely connected to FDA-regulated industries and is therefore better suited to protect public health."

Most experts contacted by MedPage Today seemed to think Califf would not have a problem getting Senate confirmation. "I expect him to be confirmed," said Nissen. "He is very well liked by people ... in both parties, and I would expect the nomination to go well."

"All signals suggest that Dr. Califf is well-respected on both sides of the political aisle," Jay Wolfson, DrPH, JD, senior associate dean at the University of South Florida's Morsani College of Medicine, in Tampa, said in an email.

"There are some who believe his relationship with [the drug industry] may be a problem, but most see it as a value-added factor in building a functional, more streamlined relationship with the industry in order to improve the speed with which truly effective and quality drugs and devices are made available, mitigate the excessive costs associated with pharmaceuticals, and influence policies and practices intended to improve health status."

Kaul said the only thing that might block Califf's confirmation "is political 'Hot Potato,'" but he added, "He is nimble enough to navigate the stormy waters."

Full Plate Ahead

If Califf is confirmed, he will have a full plate at FDA, said Robert Field, PhD, MPH, JD, professor of law and public health at Drexel University in Philadelphia. "One of the top goals will be to speed up clinical trials to bring drugs to market faster, and establish new pathways for bioengineered and genomic drugs, which will be quite a challenge to work with," he said.

The FDA "is becoming the focus for a tremendous amount of health policy...because the issues they deal with are becoming so much more central to healthcare," Field continued. "For example, the path to personalized medicine runs right through the FDA. Is [the agency] going to be a toll booth or a roadblock?"

Another big issue FDA faces is regulating tobacco and e-cigarettes, he said. "The agency is going to have to make pretty crucial decisions on how to address that." And finally, there is the "sleeper issue" of food safety.

"The food side is half of [FDA's] responsibilities -- it's what the agency's name starts out with. Many people die or get seriously ill each year from improperly processed foods," said Field. "The FDA has begun the process to be more aggressive, but that triggers reactions from a whole different industry -- and in that case, it's an industry [Califf] hasn't been affiliated with."

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